Periodontal Infection and Endothelial Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jorge Hernán Ramírez, Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT00681564
First received: May 19, 2008
Last updated: March 31, 2014
Last verified: March 2014
Results First Received: November 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Periodontitis
Interventions: Procedure: One-Stage Full-Mouth Disinfection
Procedure: Periodontal care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
rom April 2008 to March 2011 three hundred and six subjects were assessed for eligibility to participate in this randomized clinical trial. One hundred and two patients were randomized to the control (n=55) and treatment group (n=47). At 12 weeks of follow-up, 47 patients (control group) and 41 patients (treatment group) completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two hundred and four patients were excluded from this study for the following reasons: no fulfillment of inclusion criteria (n=183), refusal to participate (n=4), not assistance to study appointments (n=15), and another reasons (n=2).

Reporting Groups
  Description
Periodontal Intervention (Experimental)

One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session

  • Tongue brushing with a 1% chlorhexidine gel (1 minute)
  • Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
  • Subgingival chlorhexidine (1%) irrigation in all pockets
  • Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
  • Basic oral hygiene instructions
  • Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
Periodontal Prophylaxis (Active Comparator)

Periodontal care: - Basic oral hygiene instructions

- Supragingival plaque removal


Participant Flow:   Overall Study
    Periodontal Intervention (Experimental)     Periodontal Prophylaxis (Active Comparator)  
STARTED     47     55  
COMPLETED     41     47  
NOT COMPLETED     6     8  
Lost to Follow-up                 6                 6  
Withdrawal by Subject                 0                 1  
Death                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Periodontal Intervention (Experimental)

One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session

  • Tongue brushing with a 1% chlorhexidine gel (1 minute)
  • Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
  • Subgingival chlorhexidine (1%) irrigation in all pockets
  • Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
  • Basic oral hygiene instructions
  • Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
Periodontal Prophylaxis (Active Comparator)

Periodontal care: - Basic oral hygiene instructions

- Supragingival plaque removal

Total Total of all reporting groups

Baseline Measures
    Periodontal Intervention (Experimental)     Periodontal Prophylaxis (Active Comparator)     Total  
Number of Participants  
[units: participants]
  47     55     102  
Age  
[units: years]
Mean ± Standard Deviation
  45.5  ± 9.4     45.5  ± 8.1     45.5  ± 6.9  
Gender  
[units: participants]
     
Female     24     30     54  
Male     23     25     48  
Race/Ethnicity, Customized [1]
[units: participants]
     
White     6     5     11  
Black     5     5     10  
Indian     0     3     3  
Mixed ethnicity     36     42     78  
Smoking status  
[units: participants]
     
Currently smoking     12     14     26  
Never smoker     24     28     52  
Former smoker     11     13     24  
Formal education  
[units: participants]
     
Elementary education (1 to 5 years)     14     17     31  
Secondary education (6 to 11 years)     22     25     47  
Higher education (12 or more years)     11     13     24  
Family monthly income [2]
[units: participants]
     
Less than $300 USD     19     23     42  
≥ $300 and ≤ $600 USD     24     22     46  
More than $600 USD     4     10     14  
Medical insurance  
[units: participants]
     
None     5     5     10  
State-subsidized healthcare     30     34     64  
Contributory regime (private insurance)     11     15     26  
Prepaid medicine plan     1     1     2  
Endothelium-dependent brachial artery flow-mediated dilatation [3]
[units: Percentage of dilation]
Mean ± Standard Deviation
  9.9  ± 7.4     9.9  ± 8.5     9.9  ± 7.9  
Serum C-reactive protein (CRP) [4]
[units: mg/L]
Mean ± Standard Deviation
  4  ± 7     3.1  ± 3.6     3.6  ± 5.4  
[1] Ethnicity self reported by the participant of this clinical trial.
[2] Economic incomes are presented in United States Dollars (USD). Exchange rate used in this study for the conversion of Colombian Pesos (COP) to USD: 2000 COP = 1 USD.
[3]

Assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours.

Flow-mediated endothelium dependent vasodilatation of the brachial artery (FMD) was determined using the technique previously described by Celermajer et al. (doi: 10.1016/0140-6736(92)93147-F.) and Coretti et al. ( doi: 10.1111/j.1399-302X.1996.tb00183.x.).

FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure.

[4]

Fasting plasma hs-CRP concentrations were determined using a solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens). Baseline serum samples were not collected for one patient randomized into the periodontal prophylaxis group because of inaccessible veins.

Number of patients analyzed:

Periodontal intervention (n=47); Periodontal prophylaxis (n=54); Total (n=101).




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brachial Artery Flow-mediated Dilation   [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ]

2.  Secondary:   High-sensitivity C-Reactive Protein   [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ]

3.  Secondary:   Total Cholesterol   [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ]

4.  Secondary:   White Blood Cell Count   [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ]

5.  Secondary:   Subgingival Microbiota   [ Time Frame: 12 weeks post-periodontal therapy ]

6.  Secondary:   LDL Cholesterol   [ Time Frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy ]

7.  Secondary:   Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)   [ Time Frame: 12 weeks post periodontal therapy ]

8.  Secondary:   Intercellular Adhesion Molecule 1 (ICAM-1)   [ Time Frame: 12 weeks post periodontal therapy ]

9.  Secondary:   Vascular Cell Adhesion Molecule 1 (VCAM-1)   [ Time Frame: 12 weeks post periodontal therapy ]

10.  Secondary:   Myeloperoxidase (MPO)   [ Time Frame: 12 weeks post periodontal therapy ]

11.  Secondary:   Matrix Metalloproteinase-9 (MMP-9)   [ Time Frame: 12 weeks post periodontal therapy ]

12.  Secondary:   Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)   [ Time Frame: 12 weeks post periodontal therapy ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
1. Patient recruitment take more time that previously expected, 2. Longer time than expected for the standardization for laboratory techniques, 3. Changes of the study personnel during patient recruitment and laboratory analysis of biological samples  


Results Point of Contact:  
Name/Title: Jorge Hernán Ramírez and Adolfo Contreras (adolfo@yahoo.com).
Organization: Universidad del Valle
phone: 5723753778
e-mail: jorge.h.ramirez00@gmail.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Jorge Hernán Ramírez, Universidad del Valle, Colombia
ClinicalTrials.gov Identifier: NCT00681564     History of Changes
Other Study ID Numbers: COLCIENCIAS 110634319239
Study First Received: May 19, 2008
Results First Received: November 26, 2013
Last Updated: March 31, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos